An Automated Drug Concentration Screening and Quality Assurance Program for Clinical Trials
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Drug Information Journal. Vol. 33, pp. 273-279, 1999 Rintcd in the USA. All rights reserved.
AN AUTOMATED DRUG CONCENTRATION SCREENING AND QUALITY ASSURANCE PROGRAM FOR CLINICAL TRIALS THADDEUS H. GRASELA,PHARMD Pharmaceutical Outcomes Research, Inc., Williamsville, New York
EDWARDJ. ANTAL,PHD Phannacia & Upjohn, Kalamazoo, Michigan
JILL FIEDLER-KELLY, MS, DARCYJ. FOIT,MBA, AND BRENDABARTH,MA Pharmaceutical Outcomes Research, Inc.. Williamsville, New York
DEANW. KNUTH,BA, BARBARA J. CAREL,MS, AND STEVEN R. Cox, PHD Pharmacia & Upjohn, Kalamazoo.Michigan
The collection and analysis of drug concentration data collected during clinical trials is growing in popularity as a mechanism for explaining variability in patient outcomes. This paper describes an automated drug concentration screening and quality assurance program to monitor the acquisition of drug dosing information and concentration time data during clinical trials. This program serves to expedite the data cleaning process, allows for monitoring of possible concentration-related safety events, screens for drugdrug interactions during the execution of clinical trials, and provides the ability to produce interim, blinded reports to the sponsor and the data safety monitoring board. The goal of this paper is to describe the operation of the program as it has been used in practice and to highlight its benefits in the development program for delavirdine mesylate, a nonnucleoside reverse transcriptase inhibitor recently approvedfor the treatment of H N infection. Key Words: Quality assurance; Pharmacokinetics; Clinical trials; AIDS
INTRODUCTION
als (1-5). These techniques, such as mixed effect modeling, can be-used to identify paHAVE been tient and disease. covariates associated with developed to allow the estimation of populaalterations in pharmacokinetics that may ultition phmacokinetic parmeters from mately explain variability in patient response concentrations measured during clinical trito treatment (6,7). In addition, these techniques can reduce the need for traditional special population pharmacokinetic studies Reprint address: Thaddeus H. Grasela. Ph&, Presi- and drug-dmg interaction studies (8,9). dent, Pharmaceutical Outcomes Research, Inc., 435 order to perfom a fixed effect model Lawrence Bell Drive, Suite 7, Williamsville, NY analysis of drug concentration data, a strat14221. E-mail: [email protected]. egy must be developed for the collection and 273
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Grasela. Antal, Fiedler-Kelly, Foit, Barth, Knuth. Carel, a d Cox
processing of blood samples for the determi- Background nation of drug concentrations (10). In addiThis program was originally developed to tion, comprehensive and accurate informasupport the clinical development program for tion regarding patient drug administration delavirdine mesylate, a nonnucleoside rehistory, and the timing of blood samples, verse transcriptase inhibitor, developed by must be collected (11,12). Pharmacia and Upjohn for the treatment of As pharmaceutical companies embark on HIV infection. Saturable metabolis
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